Cuthrell P
Home Health Care Department of Children's Hospital Medical Center, Cincinnati, Ohio, USA.
J Intraven Nurs. 1996 Sep-Oct;19(5):264-8.
The Safe Medical Devices Act (SMDA) has two major effects for the user facilities: the reporting of specific medical device-related incidents and the tracking of medical devices through the user facility. As the final ruling becomes effective in 1996, it is imperative that healthcare professionals take an active role in identifying the effects of the SMDA and the impact that it poses on healthcare facilities. This article supports nursing's role in developing a medical device tracking process. Included in the overall plan to promote the user supporting system successfully are such ideas as employee education about medical equipment safety, development of unit-based medical device resource materials for employees to access, and promotion of the steps for reporting a medical device malfunction.
《安全医疗器械法案》（SMDA）对使用机构有两个主要影响：报告特定的与医疗器械相关的事件以及通过使用机构追踪医疗器械。由于最终裁决于1996年生效，医疗保健专业人员必须积极参与确定SMDA的影响及其对医疗机构造成的冲击。本文支持护理工作在制定医疗器械追踪流程中所起的作用。成功推广用户支持系统的总体计划包括以下内容，如对员工进行医疗设备安全方面的教育、开发供员工使用的基于科室的医疗器械资源材料，以及宣传报告医疗器械故障的步骤。
